Equipment/Test Method Development and Validation
- Experience with equipment & test method development and validation for Class-III medical devices
- Experience with GxP and Quality Management System (FDA 21 CFR 820.70, 72, 75 & 250, ISO 13485)
- Extensive experience in preparing pre-qualification (URS, FRS, DDS, DQ, VMP) and qualification (IQ, OQ, PQ) documents in highly-regulated environment
- Experience with root cause analysis, risk assessment, change control, FMEA
- Proficient in measurement system analysis, DOE, and statistical process control
Optical Metrology
- Familiarized with 11979-2: 2014 (Ophthalmic implants -Optical properties and test methods)
- Strong hands-on experience ...
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